A Phase I/II Trial to Assess the Safety and Tolerance of Escalating Doses of a Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Retinitis

To determine the safety and tolerance of 3 dosage levels of human anti-cytomegalovirus (CMV) monoclonal antibody (SDZ MSL-109) when administered once every 2 weeks for a total of 8 doses during the maintenance phase of ganciclovir (DHPG) therapy to patients with AIDS and documented evidence of CMV retinitis. In addition for those patients with positive CMV cultures upon entry into this trial a preliminary attempt will be made to assess the potential in vivo antiviral effects of the concomitant administration of DHPG and SDZ MSL-109.

A Phase I/II Trial to Assess the Safety and Tolerance of Escalating Doses of a Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Retinitis

Experimental maintenance or prophylactic therapy with an approved therapeutic agent for a non-viral opportunistic infection.

Trimethoprim / sulfamethoxazole (TMP / SMX).

Pyrimethamine / sulfadoxine.

Aerosolized pentamidine.

Ketoconazole.

Flucytosine (5-FC).

Antituberculosis therapy.

Concurrent Treatment:

Allowed:

Maintenance phase of ganciclovir (DHPG) therapy.

Patients must have:

AIDS with documented ophthalmologic findings consistent with cytomegalovirus (CMV) retinitis whose retinal lesions are less than 750 microns from the fovea and who have visual symptoms of CMV retinitis.

Completed the treatment induction phase with ganciclovir (DHPG) and be about to participate in the maintenance phase DHPG therapy.

Expected survival of = or > 6 months.

Willingness and ability to give written informed consent. A copy of the signed and witnessed consent form must be maintained with the investigator's study files.

Seropositive for the presence of circulating anti-CMV immunoglobulin.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

Significant pulmonary dysfunction.

Uncontrolled or unstable diabetes.

Significant cardiovascular disease including uncontrolled hypertension, congestive heart failure, cardiac arrhythmia, angina pectoris, or a history of myocardial infarction within one year of entry into the study.

Prior treatment with monoclonal antibodies derived from any animal species.

Prior Treatment:

Excluded within 2 weeks of study entry:

Major surgery.

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00002016